Baricitinib significantly improved the signs and symptoms of moderate to severe atopic dermatitis compared with placebo, according to results from two phase 3 studies, BREEZE-AD1 and BREEZE-AD2, presented at the World Congress of Dermatology.
The trials were identical — randomized, double-blind, placebo-controlled phase 3 monotherapy. BREEZE-AD1 included 624 adults with moderate to severe atopic dermatitis and BREEZE-AD2 included 615.
Patients were randomized in a 2:1:1:1 fashion to one of four arms: placebo or Olumiant (baricitinib, Eli Lilly) 1 mg, 2 mg or 4 mg daily for 16 weeks.
Skin clearance endpoints were defined as achieving a Validated Investigator’s Global Assessment for AD score of 0 or 1 and a 2-point or greater improvement from baseline at week 16.
In both studies, significantly more patients assigned to baricitinib 4 mg and 2 mg achieved skin clearance compared with placebo. Specifically, in BREEZE-AD1, 16.8% of patients in the 4-mg group (P < .01) and 11.4% of those in the 2-mg group (P < .05) achieved the primary endpoint of skin clearance. In BREEZE-AD2, 13.8% of patients in the 4-mg group (P < .01) and 10.6% in the 2-mg group (P < .05) achieved the primary endpoint. In the placebo groups, 4.8% of patients met the endpoint in BREEZE-AD1 and 4.5% of patients in BREEZE-AD2.
Moreover, in both trials significantly more patients achieved an Eczema Area and Severity Index-75 on baricitinib 4 mg (P ˂ .05; BREEZE-AD1: 24.8%, BREEZE-AD2: 21.1%,) and 2 mg (P ˂ .05; BREEZE-AD1: 18.7%, BREEZE-AD2: 17.9%) compared with placebo (BREEZE-AD1: 8.8%, BREEZE-AD2: 6.1%).
There was also a significant improvement in itch as early as week 1 in the 4-mg group and week 2 in the 2-mg group. Additional improvements by week 1 were seen for nighttime awakenings, skin pain, Dermatology Life Quality Index and Patient-Oriented Eczema Measure in both 2-mg and 4-mg treatment groups, according to the study abstract.
Adverse events were reported in 55% of patients on placebo, 54% on baricitinib 1 mg, 58% on baricitinib 2 mg and 56% on baricitinib 4 mg. Serious adverse events were reported in 3% of patients on placebo, 4% on 1 mg, 1.2% on 2 mg and 1.2% on 4 mg.
Disclosures: The authors report no relevant financial disclosures.
For more information:
Simpson E, et al. Efficacy and safety of baricitinib in moderate-to-severe atopic dermatitis: results of two phase 3 monotherapy randomized, double-blind, placebo-controlled 16-week trials (BREEZE-AD1 and BREEZE-AD2). Presented at: 24th World Congress of Dermatology; June 10-15, 2019; Milan.